1513-0084 Supporting Statement (2016-04-12)

DEPARTMENT OF THE TREASURY

ALCOHOL AND TOBACCO TAX AND TRADE BUREAU

Supporting Statement –– Information Collection Request

OMB Control Number 1513–0084

Information Collection Request Title: Labeling of Sulfites in Alcohol Beverages.

A. Justification

1. What are the circumstances that make this collection of information necessary, and what legal or administrative requirements necessitate the collection? Also align the information collection to TTB’s Line of Business/Sub-function and IT Investment, if one is used.

The Food and Drug Administration (FDA) has found that sulfating agents can produce allergic-type responses in humans and that the presence of these ingredients in food may have serious health implications for persons who are intolerant of sulfites, particularly asthmatics. To enable consumers who are sensitive to sulfites to minimize their exposure to such ingredients, the FDA in its regulations at 21 CFR 101.100(a)(4) requires food labels to declare the presence of sulfites if there are 10 parts per million or more of a sulfating agent in a finished food. See “Food Labeling; Proposed Rule Concerning Sulfiting Agents,” April 3, 1985, 50 FR 13306, and “Food Labeling; Declaration of Sulfiting Agents,” July 9, 1986, 51 FR 25012.

The Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), vests the Secretary of the Treasury with broad authority to prescribe regulations that will provide “adequate information” to consumers regarding the identity and quality of alcohol beverages. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act and its related regulations pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary also has delegated various authorities through Treasury Department Order 120–01 to the TTB Administrator to administer and enforce the FAA Act.

Under this authority, TTB has prescribed labeling requirements in its regulations in 27 CFR parts 4, 5, and 7, for wines, distilled spirits, and malt beverages, respectively. Consistent with the FAA Act and the determinations made by the FDA, TTB has issued regulations, codified at 27 CFR 4.32(e) for wine, 5.32(b)(7) for distilled spirits, and 7.22(b)(6)) for malt beverages, that require a declaration of sulfites on the labels of alcohol beverages released from domestic bottling premises or customs custody when sulfites are present in such products at levels of 10 or more parts per million (ppm).

This information collection is aligned with ––

• Line of Business/Sub-function: Law Enforcement/Substance Control.

• IT Investment: None.

2. How, by whom, and for what purpose is this information used?

In accordance with TTB’s consumer protection responsibilities under the FAA Act, we require label disclosure statements on all alcohol beverage products released from domestic bottling premises or customs custody that contain 10 parts ppm or more of sulfites because sulfiting agents at and above that level have been shown to produce allergic-type responses in humans, particularly asthmatics. The presence of these ingredients in alcohol beverages may have serious health implications for consumers who are intolerant of sulfites, and disclosure of the existence of these levels of sulfites on the labels of alcohol beverages allows such persons to minimize their exposure to these ingredients.

3. To what extent does this collection of information involve the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology? What consideration is given to use information technology to reduce burden?

TTB believes that improved information technology would not prove cost effective as a means for reducing burden, since this collection information is a third party disclosure that must appear on the actual labels of alcohol beverage products.

4. What efforts are used to identify duplication? Can similar information already available be used or modified for use for the purposes described in Item 2 above?

Efforts to identify duplication are not applicable to the collection of information for the purpose of disclosure to the general public through labeling or advertising.

5. If this collection of information impacts small businesses or other small entities, what methods are used to minimize burden?

This information collection requirement is necessary to protect consumers who are sensitive to sulfites in alcohol beverages, and it is considered to be the minimum necessary to ensure compliance. Because this information collection is necessary for consumer protection, the collection’s burden cannot be reduced based on the size of the respondent’s business.

6. What consequences to Federal program or policy activities and what, if any, technical or legal obstacles to reducing burden will occur if this collection is not conducted or is conducted less frequently?

Respondents complete this information collection only as necessary to comply with the TTB regulations requiring a declaration of sulfites on alcohol beverage labels. If this collection was not conducted, consumers sensitive to sulfites would not be aware of their presence in alcohol beverage products that they might consume.

7. Are there any special circumstances associated with this information collection that would require it to be conducted in a manner inconsistent with OMB guidelines?

There are no special circumstances associated with this information collection.

8. What effort was made to notify the general public about this collection of information? Summarize the public comments that were received and describe the action taken by the agency in response to those comments.

A 60-day Federal Register notice was published for this information collection on Wednesday, February 24, 2016, 81 FR 9245. The notice solicited comments from the general public. TTB received no comments.

9. Was any payment or gift given to respondents, other than remuneration of contractors or grantees? If so, why?

No payment or gift is associated with this collection.

10. What assurance of confidentiality was provided to respondents, and what was the basis for the assurance in statute, regulations, or agency policy?

Assurances of confidentiality are not applicable for this third-party disclosure.

11. What is the justification for questions of a sensitive nature? If personally identifiable information (PII) is being collected in an electronic system, identify the Privacy Impact Assessment (PIA) that has been conducted for the information collected under this request and/or the Privacy Act System of Records notice (SORN) issued for the electronic system in which the PII is being stored.

This information collection contains no questions of a sensitive nature. In addition, this information collection is a third-party disclosure, and, as such, it does not collect personally identifiable information (PII) in an electronic system. Therefore, no Privacy Impact Assessment (PIA) or System of Records Notice (SORN) is required for this collection.

12. What is the estimated hour burden of this collection of information?

The burden for the collection of required information contained in this information collection is estimated to be as follows:

Total number of alcohol beverage industry members: 29, 288

No. of respondents¹ affected by requirement: 19,197

This requirement will have the following results:

No. of respondents: 19,197

Frequency of annual responses: 1

Time per response: 40 minutes

Annual burden hours: 12,798

13. What is the estimated annual cost burden to respondents or record keepers resulting from this information collection request (excluding the value of the hour burden in Question 12 above)?

There is no additional cost to respondents associated with this information collection since the labeling of alcohol beverages is a usual and customary business practice.

14. What is the annualized cost to the Federal Government?

As a third-party disclosure made on alcohol beverage labels by industry members, there is no cost to the Federal Government associated with this information collection.

15. What is the reason for any program changes or adjustments reported?

There are no program changes associated with this information collection.

As for adjustments, TTB is increasing the number of respondents from 18,163 to 19,197, and, as result, the resulting annual burden hours increase from 12,109 to 12,798. This increase is due to the growth in the number of alcohol beverage producers and importers regulated by TTB, a portion of whom use sulfiting agents at level at or above 10 ppm in their products.

16. Outline plans for tabulation and publication for collections of information whose results will be published.

The results of this collection will not be published.

17. If seeking approval to not display the expiration date for OMB approval of this information collection, what are the reasons that the display would be inappropriate?

This information collection is a third-party disclosure made on the labels of alcohol beverages containing sulfiting agents at 10 ppm or more, and, as such, there is no prescribed TTB form for this collection. As such, there is no medium on which TTB can display the collection’s expiration date.

18. What are the exceptions to the certification statement?

(c) See item 5 above.

(f) This is not a recordkeeping requirement.

(i) No statistics are involved.

(j) See item 3 above.

B. Collections of Information Employing Statistical Methods.

This collection does not employ statistical methods.

1 TTB has determined the affected respondents represent a portion of all permittees as follows: 1% of Distilled Spirits Plants, 5% of Brewers, 80% of Alcohol Beverage Importers, and 100% of Bonded Wineries.